Clinical Outcomes Study of the Nexel Total Elbow

Sponsor

Zimmer Biomet (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02469662

Collaborator

(none)

120

Enrollment

Locations

Arms

162

Duration (Months)

10.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

Condition or Disease	Intervention/Treatment	Phase
Elbow Joint Destruction Post-traumatic Lesions Ankylosed Joints Advanced Rheumatoid Arthritis Joint Instability or Loss of Motion Acute Comminuted Articular Fracture of Elbow Joint Surfaces Bone Loss Contributing to Elbow Instability Bilateral Ankylosis From Causes Other Than Active Sepsis Post-traumatic Arthritis Degenerative Arthritis	Device: Nexel Total Elbow	N/A

Detailed Description

The objectives of the study are to confirm safety and performance of the Zimmer® Nexel™ Total Elbow when used in primary or revision total elbow replacement by analysis of standard scoring systems, radiographs, and adverse event records.

The safety of the device will be monitored using the frequency and incidence of reporting adverse events.

The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Retrospective Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available	Device: Nexel Total Elbow Nexel Total Elbow used in primary or revision total elbow arthroplasty Other Names: Nexel Elbow Nexel
Experimental: Prospective Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow	Device: Nexel Total Elbow Nexel Total Elbow used in primary or revision total elbow arthroplasty Other Names: Nexel Elbow Nexel

Arm

Intervention/Treatment

Experimental: Retrospective

Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available

Device: Nexel Total Elbow

Nexel Total Elbow used in primary or revision total elbow arthroplasty

Other Names:

Nexel Elbow

Nexel

Experimental: Prospective

Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow

Device: Nexel Total Elbow

Nexel Total Elbow used in primary or revision total elbow arthroplasty

Other Names:

Nexel Elbow

Nexel

Outcome Measures

Primary Outcome Measures

Survivorship [10 years]
Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is 18 years of age or older.
Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent.
Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following:
Elbow joint destruction which significantly compromises daily living activities
Post-traumatic lesions or bone loss contributing to elbow instability
Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis
Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain
Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.

Additional Retrospective Arm Inclusion Criteria

Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit.
Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted.

Exclusion Criteria:

Patient has a currently active or history of repeated local infection at the surgical site.
Patient has a current major infection distant from the operative site.
Patient has a history of prior sepsis.
Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
Patient has significant ipsilateral hand dysfunction.
Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage.
Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and/or competitive sports.
Patient is a prisoner.
Patient is mentally incompetent or unable to understand what participation in the study entails.
Patient is a known alcohol or drug abuser.
Patient is anticipated to be non-compliant.
Patient is known to be pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Panorama Orthopedics and Spine Center	Golden	Colorado	United States	80401
2	OrthoCarolina Research Institute	Charlotte	North Carolina	United States	28207
3	Rothman Institute	Philadelphia	Pennsylvania	United States	19107
4	Campbell Clinic	Germantown	Tennessee	United States	38138
5	Sydney Shoulder & Elbow, NSW	Sydney	New South Wales	Australia	2067
6	Coxa Hospital	Tampere		Finland
7	Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)	Toulouse		France
8	Arcus Sportklinik	Pforzheim		Germany
9	AO Mauriziano	Torino		Italy	10128
10	Amphia Ziekenhuis Breda	Breda		Netherlands
11	Wrightington	Wigan		United Kingdom